510(k) K040085
K040085 is an FDA 510(k) premarket notification submitted by Qualis, Inc. for the device "PERSONAL WARMING LUBRICANT". The FDA issued a decision of Substantially Equivalent on April 20, 2004. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300. Qualis, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 20, 2004
- Date Received
- January 16, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Condom
- Device Class
- Class II
- Regulation Number
- 884.5300
- Review Panel
- OB
- Submission Type